Trials / Unknown
UnknownNCT02442648
B-Cell Targeted Carfilzomib Desensitization
B-Cell Targeted Desensitization With Carfilzomib for Preformed Anti-HLA Antibodies in Patients Awaiting Kidney Transplantation
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- E. Steve Woodle · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to provide a preliminary evaluation of the safety and potential efficacy of carfilzomib in reducing HLA antibody levels in highly sensitized kidney transplant candidates.
Detailed description
This study is a non-randomized, open label, iterative pilot study. The duration of study will include a 16 month enrollment period and 5 to 6 months of follow-up. A total of 32 patients, male and female, between the ages 18 to 65 will be enrolled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Carfilzomib | Carfilzomib will be administered for desensitization per study protocol. |
| DRUG | Rituximab | Rituximab will be administered for desensitization per study protocol. |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2021-06-01
- Completion
- 2021-09-01
- First posted
- 2015-05-13
- Last updated
- 2020-06-30
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02442648. Inclusion in this directory is not an endorsement.